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Measuring Sleep Disturbance Among Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505544
First received: July 19, 2007
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

Objectives:

Primary Objectives:

  1. To establish concurrent criterion-related validity of the Brief Sleep Disturbance Scale (BSDS) by correlating the scale with the Pittsburgh Sleep Quality Index.
  2. To evaluate the construct validity of the BSDS through exploratory factor analysis.
  3. To examine possible predictors of sleep disturbance.
  4. To evaluate the reliability of the BSDS using Cronbach's coefficient alpha and test-retest reliability.
  5. To evaluate the sensitivity of the BSDS by administering it to the same group of patients (n = 60) prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment.
  6. To evaluate the psychometric properties of the BSDS in a sample of community dwelling adults.

Secondary Objective:

1. To obtain pilot data from a small sample of patients who will wear an actigraph for one week.


Condition Intervention
Advanced Cancer
Behavioral: Questionnaire
Device: Actigraph

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Brief Sleep Disturbance Scale: Measuring Sleep Disturbance Among Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Sensitivity of Brief Sleep Disturbance Scale (BSDS) [ Time Frame: Administering to same group prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 570
Study Start Date: August 2005
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire
Questionnaires that ask about your sleep, symptoms, and mood.
Behavioral: Questionnaire
Questionnaires that ask about your sleep, symptoms, and mood.
Other Name: Survey
Questionnaire + Actigraphs
Questionnaires that ask about your sleep, symptoms, and mood. Wear actigraph to collect information on activity levels and sleep patterns for one week.
Behavioral: Questionnaire
Questionnaires that ask about your sleep, symptoms, and mood.
Other Name: Survey
Device: Actigraph
Wear actigraph to collect information on activity levels and sleep patterns for one week.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study participants with a pathological diagnosis of cancer and community dwelling adults who attend a meeting of a designated service organization.

Criteria

Inclusion Criteria:

  1. Outpatient or inpatient receiving evaluation, treatment, or follow-up care at MDACC or a collaborating site.
  2. Has a pathological diagnosis of cancer.
  3. 18 years of age or older.
  4. Able to understand English.
  5. Gives informed consent to participate.
  6. Community sample eligibility: Community dwelling adult who attends a meeting of a designated service organization.
  7. Community sample eligibility: 18 years of age or older
  8. Community sample eligibility: Gives Informed Consent to participate.
  9. Community sample eligibility: Able to understand English.

Exclusion Criteria:

  1. Cannot understand the intent of the study.
  2. Patient feels too ill to complete the surveys.
  3. Refuses to participate.
  4. Community sample exclusion criterion: Unable to complete the surveys.
  5. Community sample exclusion criterion: Refuses to participate.
  6. Community sample exclusion criterion: Cancer diagnosis (past or present).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505544

Locations
United States, Texas
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Tito Mendoza, PHD, MS, MED, BS M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505544     History of Changes
Other Study ID Numbers: 2004-0598
Study First Received: July 19, 2007
Last Updated: October 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Questionnaire
Survey
Sleep Disturbance
Sleep Quality

Additional relevant MeSH terms:
Dyssomnias
Parasomnias
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014